Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claims filed 6/28/23. Claims 1-14 are pending and under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that:
It is noted that previous applications in this family, such as parent application 17/168325 (now US 11732019), was filed before July 1, 2022 and so were required to comply with ST.25 standards, which allowed but did not require identification of sequences in a branched or cyclic sequence. The instant application has an actual filing date (not effective filing date) of 6/28/23, which is after the 7/1/22 date. Further, the instant application is a CON and so is not excepted as a national stage entry (371) application. As such, the instant application must comply with the ST.26 standard, which requires identification of sequences even in cyclic or branched sequences.
Formula I contains the enumerated amino acid sequence of ASPEELNRYY. ST.26 paragraph 94 states, “Any variant sequence, disclosed as a single sequence with enumerated alternative residues at one or more positions, must be included in the sequence listing and should be represented by a single sequence, wherein the enumerated alternative residues are represented by the most restrictive ambiguity symbol (see paragraphs 15 and 27).” Annex VI further states that “Where a sequence that meets the requirements of paragraph 7 is disclosed by enumeration of its residues only once in an application, but is described differently in multiple embodiments, e.g., one embodiment “X” in one or more locations could be any amino acid, but in further embodiments, “X” could be only a limited number of amino acids, ST.26 requires inclusion in a sequence listing of only the single sequence that has been enumerated by its residues.”
The sequences supplied in the sequence listing appear to be directed at variant sequences of formula I, but lacks a specific identifier for the invariant sequence identified above. The “z” variables in this case fall under the paragraph 7 definition of a residue that may be described differently in multiple embodiments, and so the requirement is for the invariant sequence of ASPEELNRYY to be included in the sequence listing and recitations of this sequence in the specification and claims shall be identified by that sequence.
Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities:
Where a sequence meeting the criteria for inclusion in the sequence listing is present in the claims, that sequence must be accompanied by the relevant SEQ ID NO; see MPEP §2412.04. Recitations of Formula I, e.g., on page 3, must be accompanied by the required SEQ ID because ASPEELNRYY is an enumerated amino acid sequence of at least four amino acids.
Further, the specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not use the phrase “metabolic disorder”. This term must be added to the specification to provide clear antecedent basis for the terminology, particularly as “metabolic syndrome” is a distinct pathology (see claim 11) but could create confusion when the specification does not explicitly use the term “metabolic disorders”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: Where a sequence meeting the criteria for inclusion in the sequence listing is present in the claims, that sequence must be accompanied by the relevant SEQ ID NO; see MPEP §2412.04. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “further comprise” should be “further comprising”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: there is a superfluous comma at the end of the sentence. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for ameliorating certain diseases, does not reasonably provide enablement for preventing or reversing those diseases, nor for preventing, treating, or ameliorating all metabolic disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: 1) nature of the invention, 2) breadth of claims, 3) amount of direction or guidance by the inventor, 4) relative skill of those in the art, 5) level of predictability in the art, 6) state of the prior art, 7) existence of working examples, and 8) quantity of the experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The nature of the invention is a compound which reduces food intake by modulating the Y2 receptor. The breadth of the claims is such that this effect will prevent obesity or diabetes as well as prevent and treat all metabolic disorders regardless of the etiology of those disorders.
Regarding preventing obesity, type 2 diabetes, etc, the specification provides evidence that the method of treatment will reduce food intake. There are no examples of preventing any disease.
Regarding treating metabolic disorders, the specification defines the term “treating” as including “preventing the progression” and “causing the regression” of the disease. Further, the definition includes alleviation (curing), prevention of the development or onset, or reduction in the duration as well as “prevention of the recurrence of the disease”. See p. 54 for these definitions.
With regard to “preventing”, the specification demonstrates that the method will reduce food intake. For example, Example 112 of the specification (starting at page 181) notes that in some cases, the treatment leads to weight loss (table 3). However, the claims are directed to wholly preventing obesity as well as preventing the recurrence of obesity. Table 3 does not indicate that obesity was prevented in these mice nor, even if it does, does the specification indicate what amounts of the compound would be effective in preventing a subject from ever becoming obese again.
With respect to preventing or reversing metabolic syndrome, it is recognized that there is an association between the syndrome and e.g., obesity or diabetes. However, there are also other causes of metabolic syndrome including other diseases such as sleep apnea or simply age and ethnicity; see Mayo (article titled “metabolic syndrome; form 892). There is no evidence to support the claim that this disorder can be fully prevented nor is there evidence that reduced food intake will cure (reverse; alleviate) a subject already suffering from metabolic syndrome.
The same rationale applies to diabetes; currently, there is no cure for type 2 diabetes (Nichols; form 892) and the claim that the instant method is capable of achieving this so-far unrealized goal is not supported by evidence. While controlled food intake may ameliorate and control the disease, reduced food intake has yet to cure a subject of type 2 diabetes.
With respect to the genus of metabolic disorders, one such disease is phenylketonuria, a genetic disorder in which a subject improperly metabolizes phenylalanine leading to a toxic build up (Mayo article titled “Phenylketonuria (PKU)”; form 892). A reduction in food intake would not alter a subject’s DNA, i.e., would not prevent PKU, and reduced food intake would not cure or even treat the disease. There is no evidence that Y2 plays a role in the activity of phenylalanine hydroxylase and so modulating this receptor would not be expected to treat PKU. This is just one of many metabolic disorders that are not strictly weight related. It is left to others to determine for themselves which of the many metabolic disorders would be treatable, preventable, or curable by reduced food intake/Y2 receptor modulation with no expectation of success or predictable treatment across the members of this genus.
Therefore, claims 9-12 are not enabled for the full scope of the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10961293. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a cyclic PYY identical to instant formula 1. The reference claims are also directed to treating, e.g., obesity, reducing food intake, and modulating Y2 receptor activity, including by adding additional agents such as GLP-1 inhibitors (claim 14) for said treatment. The reference claims claim modulating Y2 receptor activity, reducing food intake, treating Type 2 diabetes, and ameliorating obesity (reference claims 8, 10, 11, 12). The reference claims anticipate the instant claims. To the extent that the reference claims are broader—such as by including one additional choice for the BRIDGE portion, the Markush groups represent a limited number of choices which are all expected to act predictably, such that the artisan could immediately envisage the various embodiments claimed, including those of the instant claims.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10968264. Although the claims at issue are not identical, they are not patentably distinct from each other for the same reasons as above. Briefly, the reference application claims the same PYY peptides as well as the same methods of treatment which combine the PYY with additional therapeutics, e.g., claims 14 and 21.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10640544. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a compound of an identical formula as the instant claims. Both the instant claims and reference claims are directed to the same PYY (formula 1) and both also contain claims to modulating Y2 receptor activity and reducing food intake as well as including a GLP-1 inhibitor (reference claim 17). In support of the claimed compositions as well as the claimed methods of treatment, the reference specification discloses the compound as useful for treating the same diseases as instantly claimed.
Claims 1-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10428134. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims include conjugation to a “therapeutic peptide” (claims 12 and 20). Those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In this case, in support of “therapeutic peptide”, the specification lists PYY (C2), including cyclic forms thereof (see figure 3). The reference claims also include, e.g., GLP1 (claim 16), which is instantly claimed.
Further, see the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. In this case, the reference patent discloses the utility in, e.g., amelioration of obesity (C16).
Note that, in supporting cyclic PYY, the reference patent explicitly refers to and incorporates application 15/794,231 (C16) as well as incorporating specific peptide-antibody conjugates of 15/794,171, further indicating that the claimed compounds are anticipated by or at least obvious over the reference patent.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10968265. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to the same PYY (formula I; claim 1) and the same methods of use (claims 16-18). The reference claims also include an additional antidiabetic agent (claim 20), which is a GLP-1 modulator (claim 21).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11591379.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to the same PYY (formula I; claim 1) and the same methods of use (claim 1). The reference claims also include an additional antidiabetic agent (claim 13), which is a GLP-1 modulator (claim 14). Moreover, administering to treat obesity or diabetes 2 as claimed in the reference document will inherently modulate Y2 and lead to reduction of food intake, as these are downstream effects of administering the claimed compound.
Claim 1-14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16-19, and 21-24 of co-pending Application No. 18154020 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are also the same compound (formula I) as instantly claimed (claim 1) in the same methods (claims 17, 18, 19). The reference claims also include additional antidiabetic agents (claim 21), including GLP1 modulators (claim 22).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11767354.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to the same PYY (formula I; claim 1) and the same methods of use (claims 1, 16). The reference claims also include an additional antidiabetic agent (claim 13), which is a GLP-1 modulator (claim 14).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11732019. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to the same PYY (formula I; claim 1) and the same methods of use (claims 8, 10, 11, 12). The reference claims also include an additional antidiabetic agent (claim 13), which is a GLP-1 modulator (claim 14).
Allowable Subject Matter
No prior art rejection is made herein. It is noted that NPY 3-36 and PYY 3-36 were known in the prior art to reduce food intake; see specification p.2, which represents the closest prior art. Further, cyclizing peptides was a known strategy to increase the half-life of therapeutics (Maria; form 892). However, in reviewing the art of record and a search of the prior art by the Examiner, there appears no rationale nor motivation to make the particular modifications as instantly claimed. PYY 3-36 is SKPEAPGEDASPEELNRYYASLRHYLNLVTRQRY. Thus, the instant compound is not merely a cyclic form of PYY 3-36, but one where the bridge is not between the terminal ends of the peptide but is a branch between residue 4 and a moeity interrupting residues 29-32. Moreover, either Z30 (residue 30) is deleted (absent) or V31 (residue 31) is deleted (q must be zero if Z30 is present). There is no evidence of record to suggest removing one of these residues nor to cyclize the peptide at these residues, leaving residues 31+ as an extension of the loop.
Taken as a whole, the evidence weighs in support of non-obviousness.
The only addition of claim 6 occurs in the preamble, requiring a “pharmaceutical composition”. However, the instant specification defines this phrase to be the compound plus a pharmaceutically acceptable carrier (p.44 L16). Thus, the preamble adds an additional limitation to the structure of the composition and so the claim provides a further limitation in compliance with §112(d).
As noted in the parent prosecution of 16/344141, the ordinary definition of “dyslipidemia” includes both hypo- and hyper- lipidemias. While limitations from the specification are not read into the claims, a reasonable interpretation of the terms is made in light of the specification. Here, the specification is clear as to how the composition is meant to affect lipids and which disorders are generally included in the treatment, so one of ordinary skill in the art could determine which dyslipidemias are reasonably within the scope of the claim, meeting the enablement requirement. Note that non-enabled embodiments are permissible when one could immediately determine which lipedemias were treatable and which were not (MPEP §2164.08(b)).
Under MPEP §2163, elements “auxiliary to the invention must have a corresponding written description only so specific as to lead one having ordinary skill in the art to that class of compounds. Occasionally, a functional recitation of those known compounds in the specification may be sufficient as that description”. In this case, the PYY compound of formula I appears to be the “invention”. Addition of, e.g., “at least one antidiabetic agent” (claim 13) or “a glucagon-like-peptide-1 receptor modulator” (claim 14) is considered an auxiliary element and direction to this class of compounds is considered sufficient to meet the written description requirement.
It is also recognized that Applicant’s portfolio of patent applications and US patents is extensive on Formula I and weight loss. Statutory double patenting was considered but in every case there exists some difference in scope, which precludes a statutory double patenting rejection. For example, previous patents and applications generally claim the BRIDGE portion as including SCH2C(O)NH, which is not an option for the instant claims. Other applications include modifications other than acylation, whereas the instant application only explicitly claims acylation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Adam Weidner/ Primary Examiner, Art Unit 1675